Sr. Director, Drug Product Development & Mfg - Kiniksa Pharmaceuticals : Job Details

Senior Director, Drug Product Development & ManufacturingReporting to the Senior VP of Technical Operations, the Senior Director of Drug Product Development & Manufacturing will provide scientific, technical, and hands-on leadership to formulation development, drug product development, combination product development and manufacturing operations for Kiniksa's pipeline programs from clinical through commercialization. This is a senior position within Technical Operations and will be expected to leverage broad product development and leadership experience to support Kiniksa's portfolio and vision.This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Job Responsibilities (including, but not limited to):Lead, manage, mentor and inspire the Drug Product team.Manage the Drug Product group budgets, including external costs and equipment.Establish overall drug product development and manufacturing strategies.Lead formulation development, drug product development, combination product development and manufacturing activities supporting pipeline programs, including manufacturability assessment, formulation and dosage form development, development of efficient and scalable manufacturing processes, technology transfer and drug product process validation.Serve as drug product SME to support CMC and program teams in technical due diligence, CRO and CMO capability assessment, selection and management.Develop, author, review and approve technical memos, study protocols and reports. Review and approve related GMP and quality documents.Author and review relevant sections in regulatory submissions (IND, BLA, MAA, etc.), including responses to inquiries from Health Authorities.Provides scientific/technical guidance, leadership and decision-making across the company.Provide input and participate in long term strategic initiatives to enable and advance effectiveness and efficiencies in product developmentStay current with the regulatory requirements, trends, and new emerging technologies as it relates to formulation development, drug product development, combination product development and manufacturing.Qualifications:Advanced degree in a scientific or engineering discipline: Ph.D. with 10+ years, MS with 15+ years, or BS with 18+ years of relevant experience, preferably in biotechnology or pharmaceutical industry.In-depth knowledge of protein chemistry, bioanalytical and biophysical techniques pertaining to protein stability and pharmaceutical development.Demonstrated technical expertise in formulation development, drug product development, process design and scale-up, and manufacturing of common parenteral drug product dosage forms.Knowledge and experiences in combination product development and production, such as pre-filled syringe, autoinjector and wearables, preferred.Experience with inhalation delivery systems is a plus.Significant experience in collaborating with CRO, CMO, drug product component suppliers and strategic development and production partners.Experienced with regulatory submission and working knowledge of industry practices and regulations (e.g., GxP, ISO, ICH, etc.) across multiple Health Authorities (e.g., FDA and EMA).Strong project management, interpersonal, communication, negotiation, and problem-solving skills.Proven ability to lead in a team environment to solve complex technical challenges.Ability to manage multiple priorities and work with ambiguity to deliver results.Leadership and managerial experience.Embodies Kiniksa values; exhibits high degree of integrity and professionalism when interacting with outside investigators and vendors.Entrepreneurial and enjoys working in a fast-paced, creative and resourceful small company environment.Ability to travel up to 5% (domestic and international).Salary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.